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Methods and devices for administration of substances into the intradermal layer of skin for systemic absorption

a systemic absorption and intradermal layer technology, applied in the direction of hormone peptides, peptide/protein ingredients, peptides, etc., can solve the problems of affecting the effect of systemic absorption

Inactive Publication Date: 2008-05-22
PETTIS RONALD J +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0012]The present disclosure relates to a new parenteral administration method based on directly targeting the dermal space whereby such method dramatically alters the pharmacokinetics (PK) and pharmacodynamics (PD) parameters of administered substances. By the use of direct intradermal (ID) administration means hereafter refereed to as dermal-access means, for example, using microneedle-based injection and infusion systems (or other means to accurately target the intradermal space), the pharmacokinetics of many substances including drugs and diagnostic substances, which can be altered when compared to traditional parental administration routes of subcutaneous and intravenous delivery. These findings are pertinent not only to microdevice-based injection means, but other delivery methods such as needleless or needle-free ballistic injection of fluids or powders into the ID space, Mantoux-type ID injection, enhanced iontophoresis through microdevices, and direct deposition of fluid, solids, or other dosing forms into the skin. Disclosed is a method to increase the rate of uptake for parenterally-administered drugs without necessitating IV access. One significant beneficial effect of this delivery method is providing a shorter Tmax (time to achieve maximum blood concentration of the drug). Potential corollary benefits include higher maximum concentrations for a given unit dose (Cmax), higher bioavailability, more rapid uptake or absorption rates (ka), more rapid onset of pharmacodynamics or biological effects, and reduced drug depot effects. According to the present invention, improved pharmacokinetics means increased bioavailability, decreased lag time (Tlag), decreased Tmax, more rapid absorption rates, more rapid onset and / or increased Cmax for a given amount of compound administered, compared to subcutaneous, intramuscular or other non-IV parenteral means of drug delivery.

Problems solved by technology

Many current attempts at preparing “closed loop” insulin pumps are hindered by the delay pod between administering the insulin and waiting for the biological effect to occur.
This makes it difficult to ascertain in real-time whether sufficient insulin has been given, without overtitrating and risking hypoglycemia.

Method used

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  • Methods and devices for administration of substances into the intradermal layer of skin for systemic absorption
  • Methods and devices for administration of substances into the intradermal layer of skin for systemic absorption
  • Methods and devices for administration of substances into the intradermal layer of skin for systemic absorption

Examples

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example i

[0065]Slow-infusion ID insulin delivery was demonstrated in swine using a hollow, silicon-based single-lumen microneedle (2 mm total length and 200×100 μm OD, corresponding to about 33 gauge) with an outlet 1.0 μm from the tip (100 μm exposed height), was fabricated using processes known in the art (U.S. Pat. No. 5,928,207) and mated to a microbore catheter (Disetronic). The distal end of the microneedle was placed into the plastic catheter and cemented in place with epoxy resin to form a depth-limiting hub. The needle outlet was positioned approximately 1 mm beyond the epoxy hub, thus limiting penetration of the needle outlet into the skin to approximately 1 mm, which corresponds to the depth of the intradermal space in swine. The catheter was attached to a MiniMed 507 insulin pump for control of fluid delivery. The patency of the fluid flow path was confirmed by visual observation, and no obstructions were observed at pressures generated by a standard 1-cc syringe. The catheter wa...

example ii

[0066]Bolus delivery of Lilly Lispro fast acting insulin was performed using ID and SC bolus administration. The ID injection microdevice was dermal access array design SS3S—34—1. 10 international insulin units (U) corresponding to 100 uL volume respectively, were administered to diabetic Yucatan Mini swine. Test animals bad been previously been rendered diabetic by chemical ablation of pancreatic islet cells, and were no longer able to secrete insulin. Test animals received their insulin injection either via the microneedle array or via a standard 30 G×½ in. needle inserted laterally into the SC tissue space. Circulating serum insulin levels were detected using a commercial chemiluminescent assay kit (Immulite, Los Angeles, Calif.) and blood glucose values were determined using blood glucose strips. ID injections were accomplished via hand pressure using an analytical microsyringe and were administered over approximately 60 sec. By comparison, SC dosing required only 2-3 sec. Refer...

example iii

[0067]Lilly Lispro is regarded as fact acting insulin, and has a slightly altered protein structure relative to native human insulin. Hoechst regular insulin maintains the native human insulin protein structure that is chemically similar, but has slower uptake than Lispro when administered by the traditional SC route. Both insulin types were administered in bolus via the ID route to determine if any differences in uptake would be discernable by this route. 5 U of either insulin type were administered to the ID space using dermal access microdevice design SS3S—34—1. The insulin concentration verses time data shown in FIG. 3. When administered by the ID route the PK profiles for regular and fast-acting insulin were essentially identical, and both insulin types exhibited faster uptake than Lispro given by the traditional SC route. This is evidence that the uptake mechanism for ID administration is minimally affected by minor biochemical changes in the administered substance, and that I...

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Abstract

Methods and devices for administration of substances into the intradermal layer of skin for systemic absorption.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation-in-part of U.S. application Ser. No. 09 / 893,746, filed Jun. 29, 2001, which is a continuation-in-part of U.S. application Ser. No. 09 / 835,243, filed Apr. 13, 2001, which is a continuation-in-part of U.S. application Ser. No. 09 / 417,671, filed Oct. 14, 1999, and claims priority to U.S. provisional application No. 60 / 301,531, filed Jun. 29, 2001, all of which are incorporated herein by reference.FIELD OF THE INVENTION[0002]The present invention relates to methods and devices for administration of substances into the intradermal layer of skin for systemic absorption.BACKGROUND OF THE INVENTION[0003]The importance of efficiently and safely administering pharmaceutical substances such as diagnostic agents and drugs has long been recognized. Although an important consideration for all pharmaceutical substances, obtaining adequate bioavailability of large molecules such as proteins that have arisen out of the b...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K38/20A61K38/21A61K38/00A61M5/158A61M5/28A61M5/30A61M5/32A61M5/46A61M37/00
CPCA61K9/0019A61K9/0021A61K38/193A61K38/24A61K38/27A61K38/28A61M2202/0445A61M5/158A61M5/46A61M37/0015A61M2037/003A61M2037/0061A61K38/29
Inventor PETTIS, RONALD J.HARVEY, NOEL G.DOWN, JAMES A.
Owner PETTIS RONALD J
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